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Идёт набор NCT03192501

iCAGES-guided Precision Therapy for Cancers in Contrast to Standard Care or IHC-guided Theray

— Наблюдательное Lung Cancer Gene Abnormality Gene Product Sequence Variation Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: inhibitors, ADC drugs such as tarceva, capmatinib, padcev et al for A/C group..
Кому может быть актуально
Состояния в реестре: Lung Cancer, Gene Abnormality, Gene Product Sequence Variation, Cancer. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Multicentre Perspective Non-interventional Study of Survival Benefits of iCAGES-guided Therapy in Contrast to Standard Therapy or IHC-guided Therapy for Advanced Cancers

Обзор

This study prospectively evaluates whether the use of iCAGES (integrated CAncer GEnome Score) tool in guiding the treatment of advanced cancers is superior to current standard care or IHC-guided therapy in progress free survival (PFS),overall survival (OS),and improvement of life quality.

Подробное описание

Cancer is a fatal disease caused by the accumulation of various oncogene and tumor suppressor gene mutations. Studies of high-throughput sequencing for patients who suffered from cancer has found that different mutations play a different role in the occurrence and development of different cancers. Several gene panels already exist to help identify mutations in a few genes that may have corresponding FDA-approved drugs or drugs under clinical trials. However, given whole-genome/exome sequencing data, the suitable clinical analysis tool to analyze individualized cancer-related gene mutations, and recommend the most appropriate targeted treatment options among hundreds of possible drugs therapy is absent currently.

The recently proposed iCAGES is a precise biomedical informatics analysis tool, which could help increase the accuracy of cancer driver gene detection and prioritization, bridge the gap between personal cancer genomic data and prior cancer research knowledge,and facilitate cancer molecular diagnosis as well as personalized precision therapy.

IHC detection of multiple molecules such as EGFR, HER2-3, TROP3, NECTIN4, MET, B7-H3-4, B1-H7, Claudin18.2, FGFR1-4, Mesothelin, ROR1, BCMA, AXL, TF, FRα, CD70, PPARα, HIF-2α, RET, ROS1, NTRK, CDK4/6, FLT3, EZH2 are also scheduled for appropriate targeted therapy and comparison if available.

Вмешательства

  • Препарат inhibitors, ADC drugs such as tarceva, capmatinib, padcev et al for A/C group.
    Choose appropriate targeted drugs according to NGS/IHC results.

Первичные конечные точки

  • PFS [Срок оценки: 2 years]
  • OS [Срок оценки: 2 years]
Вторичные конечные точки (2)
  • Quality of life. [Срок оценки: 2 years]
  • Pain [Срок оценки: one year]

Критерии участия

Критерии включения

  • Pathological and clinical diagnosis of recurrence / metastatic lung cancer or other advanced cancers.
  • There are PACS images available at the Second Affiliated Hospital of Guangzhou Medical University and the collaborated Hospitals.
  • The patient is informed consent and signed a written consent.

Критерии исключения

  • Age > 70 or <18 years old.
  • Previous history of malignant tumors.
  • Pregnant or lactating female patients.
  • Any serious concomitant disease that is expected to have an adverse effect on prognosis, including the heart disease that treatment is required, unsatisfactory controlled diabetes and psychiatric disorders.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • The Second Affiliated Hospital of Guangzhou Medical University — Гуанчжоу

Публикации

  • Dong C, Guo Y, Yang H, He Z, Liu X, Wang K. iCAGES: integrated CAncer GEnome Score for comprehensively prioritizing driver genes in personal cancer genomes. Genome Med. 2016 Dec 22;8(1):135. doi: 10.1186/s13073-016-0390-0. PMID 28007024

Идентификаторы

NCT: NCT03192501 · ZZiCAGES-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗